BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2100661 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03590
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION WHICH REPORTED THE EROSION OF THE INS 6 WEEKS POST OPERATIVELY. THE HCP DID A CULTURE WHICH TESTED POSITIVE FOR (B)(6). THE PHYSICIAN REMOVED THE INS AND LEAD AND DISPOSED OF BOTH. THE DOCTOR INTENDS TO RE-IMPLANT BECAUSE THE PT HAD GOOD RESULTS BUT NEEDS TO MAKE SURE THE INFECTION IS GONE BEFORE ANY RE-IMPLANTATION PLANS ARE MADE. PHYSICIAN STATED THE PT IS DOING FINE. UPON FURTHER REVIEW, MFR REPORT # 3007566237-2011-03296 WAS FOUND TO BE A DUPLICATE OF THIS REPORT. ALL FUTURE INFORMATION WILL BE FILED IN THIS REPORT. "RECEIVED INFORMATION OF EROSION OF THE DEVICE THROUGH THE PT'S SKIN SIX WEEKS POST-OPERATIVELY. THE PT WAS DIAGNOSED WITH (B)(6) SO THE INS AND LEAD WERE EXPLANTED AND DISPOSED OF BY THE HOSPITAL. THE PT HAD GOOD RESULTS FROM THE DEVICE SO THE PHYSICIAN PLANS TO REIMPLANT THE DEVICE SYSTEM ONCE THE INFECTION IS CLEARED. THE PT WAS REPORTED AS DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NAH0285291

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD102607N| LEAD: MODEL 3093, LOT# V625667| EXPLANTED: